Phase 4 Cardiac Surgery Ketamine Anti-inflammatory Trial NCT07536633
Summary
NIH ClinicalTrials.gov registered a Phase 4 clinical trial (NCT07536633) investigating the anti-inflammatory effect of ketamine in cardiac surgery patients. The randomized controlled study will evaluate intraoperative ketamine administration (1 mg/kg induction plus 2.4 mg/kg/h maintenance infusion) versus control on inflammatory markers including neutrophil-to-lymphocyte ratio, systemic immune-inflammation index, and C-reactive protein. The trial targets adult cardiac surgery patients and will assess pain scores, hospital mortality, and morbidity outcomes.
What changed
NIH registered a Phase 4 clinical trial on ClinicalTrials.gov to investigate ketamine's anti-inflammatory properties in cardiac surgery patients. The randomized study divides patients into ketamine and control groups, with the ketamine group receiving 1 mg/kg ketamine during anesthesia induction followed by continuous intravenous infusion of 2.4 mg/kg/h for maintenance. Researchers will measure multiple inflammatory parameters preoperatively and on postoperative day 1, including leukocyte, neutrophil, lymphocyte, and platelet counts; neutrophil-to-lymphocyte ratio; systemic immune-inflammation index; and C-reactive protein. Pain scores within 24 hours of extubation and hospital mortality and morbidity rates will also be evaluated.
For compliance officers and legal professionals, this represents a registered clinical investigation rather than a regulatory action. Healthcare providers and clinical investigators considering participation should ensure appropriate IRB oversight, informed consent procedures, and adverse event reporting mechanisms align with FDA requirements. The trial does not impose new compliance obligations on non-participating entities.
Archived snapshot
Apr 18, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Investigation of the Anti-inflammatory Effect of Ketamine in Cardiac Surgery
Phase 4 NCT07536633 Kind: PHASE4 Apr 17, 2026
Abstract
Background:
The inflammatory response following cardiac surgery is known to contribute significantly to morbidity and mortality. Neutrophils and inflammatory mediators play a critical role in the pathogenesis of postoperative complications. The aim of this study was to evaluate the effect of intraoperative ketamine administration on the inflammatory response in patients undergoing cardiac surgery using routinely employed immuno-inflammatory parameters in clinical practice.
Methods:
After randomization, patients were divided into two groups: the ketamine group and the control group. Following admission to the operating room, standard monitoring and anesthesia induction were performed. In addition to the control group, patients in the ketamine group received 1 mg/kg ketamine during induction and a continuous intravenous infusion of 2.4 mg/kg/h ketamine for maintenance.
Immuno-inflammatory parameters were assessed using routine blood tests obtained preoperatively and on postoperative day 1. These parameters included leukocyte, neutrophil, lymphocyte, and platelet counts; neutrophil-to-lymphocyte ratio (NLR); platelet-to-lymphocyte ratio (PLR); NLR index; delta NLR; ΔPLR; PLR index; systemic inflammatory response index (SIRI); systemic immune-inflammation index (SII); and C-reactive protein (CRP), ΔCRP, and CRP index. In addition, patients' pain scores within the first 24 hours following postoperative extubation, as well as hospital mortality and morbidity rates, were eval...
Conditions: Cardiac Surgery
Interventions: ketamine
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